title: First human use of an allogeneic tissue-engineered vascular graft for hemodialysis access.
abstract: An arteriovenous fistula is the current gold standard for chronic hemodialysis access. Tunneled catheters or synthetic grafts have poorer outcomes and much higher risks of infection. This report presents the first clinical use of a completely biological, allogeneic, nonliving, and human tissue-engineered vascular graft. Tissue-engineered vascular grafts built from allogeneic fibroblasts were implanted as shunts in three hemodialysis patients. The tissue-engineered vascular graft was stored for 9 months, without loss of mechanical strength. Implanted grafts showed no signs of degradation or dilation, with time points up to 11 months. Results of panel-reactive antibody and cross-reactivity tests showed no evidence of immune responses.
authors.affiliation: Department of General, Vascular, and Transplant Surgery, Medical University of Silesia, Katowice, Poland.
authors.forename: Wojciech
authors.initials: W
authors.lastname: Wystrychowski
authors.affiliation: Cytograft Tissue Engineering, Inc, Novato, Calif.
authors.forename: Todd N
authors.initials: TN
authors.lastname: McAllister
authors.affiliation: Department of General, Vascular, and Transplant Surgery, Medical University of Silesia, Katowice, Poland.
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Zagalski
authors.affiliation: Cytograft Tissue Engineering, Inc, Novato, Calif.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Dusserre
authors.affiliation: Department of General, Vascular, and Transplant Surgery, Medical University of Silesia, Katowice, Poland.
authors.forename: Lech
authors.initials: L
authors.lastname: Cierpka
authors.affiliation: Cytograft Tissue Engineering, Inc, Novato, Calif. Electronic address: nico@cytograft.com.
authors.forename: Nicolas
authors.initials: N
authors.lastname: L'Heureux
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001166:Arteriovenous Shunt, Surgical / Q000009:adverse effects / Q000295:instrumentation*; D001705:Bioprosthesis; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D002478:Cells, Cultured; D005260:Female; D005347:Fibroblasts / Q000276:immunology / Q000637:transplantation*; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D006435:Renal Dialysis; D013997:Time Factors; D023822:Tissue Engineering / Q000379:methods*; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D018608:Ultrasonography, Doppler